[go: up one dir, main page]

WO2007089295B1 - Process for aseptic vacuum filling and stoppering of low viscosity liquids in containers - Google Patents

Process for aseptic vacuum filling and stoppering of low viscosity liquids in containers

Info

Publication number
WO2007089295B1
WO2007089295B1 PCT/US2006/041460 US2006041460W WO2007089295B1 WO 2007089295 B1 WO2007089295 B1 WO 2007089295B1 US 2006041460 W US2006041460 W US 2006041460W WO 2007089295 B1 WO2007089295 B1 WO 2007089295B1
Authority
WO
WIPO (PCT)
Prior art keywords
process according
filling
containers
stoppering
fluid
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2006/041460
Other languages
French (fr)
Other versions
WO2007089295A3 (en
WO2007089295A2 (en
Inventor
Shawn Kinney
Andrea Wagner
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Hyaluron Inc
Original Assignee
Hyaluron Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US11/584,914 external-priority patent/US20070169434A1/en
Application filed by Hyaluron Inc filed Critical Hyaluron Inc
Publication of WO2007089295A2 publication Critical patent/WO2007089295A2/en
Publication of WO2007089295A3 publication Critical patent/WO2007089295A3/en
Publication of WO2007089295B1 publication Critical patent/WO2007089295B1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B3/003—Filling medical containers such as ampoules, vials, syringes or the like
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B31/00—Packaging articles or materials under special atmospheric or gaseous conditions; Adding propellants to aerosol containers
    • B65B31/04—Evacuating, pressurising or gasifying filled containers or wrappers by means of nozzles through which air or other gas, e.g. an inert gas, is withdrawn or supplied
    • B65B31/046—Evacuating, pressurising or gasifying filled containers or wrappers by means of nozzles through which air or other gas, e.g. an inert gas, is withdrawn or supplied the nozzles co-operating, or being combined, with a device for opening or closing the container or wrapper
    • B65B31/047—Evacuating, pressurising or gasifying filled containers or wrappers by means of nozzles through which air or other gas, e.g. an inert gas, is withdrawn or supplied the nozzles co-operating, or being combined, with a device for opening or closing the container or wrapper the nozzles co-operating with a check valve in the opening of the container or wrapper
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B7/00—Closing containers or receptacles after filling
    • B65B7/16—Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons
    • B65B7/28—Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons by applying separate preformed closures, e.g. lids, covers
    • B65B7/2821—Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons by applying separate preformed closures, e.g. lids, covers applying plugs or threadless stoppers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/1782—Devices aiding filling of syringes in situ

Landscapes

  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Chemical & Material Sciences (AREA)
  • Dispersion Chemistry (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Basic Packing Technique (AREA)
  • Vacuum Packaging (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

A process and method by which low viscosities liquids are filled into containers, such as syringes, without gas bubbles utilizing lowered temperature and valves to isolate the filling system from the vacuum. The liquid may be drug, device, pharmaceutical, and/or biotech products.

Claims

received by the International Bureau on 18 October 2007 (18.10.2007)
1. A process for removing gas bubbles from a low viscosity fluid, the process comprising filling containers under aseptic conditions with sterile fluid; and stoppering the containers, wherein filling and stoppering steps are performed under a vacuum utilizing check valves to isolate fill lines, and lowered temperature to suppress vapor pressure of the low viscosity fluid being filled.
2. The process according to cJaim 1 , wherein the lowered temperature is obtained by a procedure selected from at least one of, cooling product feed into filling pumps, placing an inline chiller on the fiJling pumps, placing an in-line chiller on the fill lines, reducing filling room temperature, chilling the containers on-line with a cold gas, and pre-chilling the contains.
3. The process according to claim 1, further comprising, prior to filling the containers, applying a pre-vacuum.
4. The process according to claim 1 , wherein the gas bubbles comprise air.
5. The process according to claim 1, wherein the gas bubbles comprise a gas other than air.
6. The process according to claim 1, wherein the extent of the vacuum is at least about 28 inches of mercury and the temperature is less than about 8 C.
7. The process according to claim 1 , wherein the extent of the vacuum is at least about 29 inches of mercury and the temperature is less than about 8 C.
8. The process according to claim 1, wherein the volume of the fluid is about 0.01 ml to about 100 ml.
9. The process according to claim 1 , further comprising prior to filling, sterilizing the fluid by filter sterilization.
10. The process according to claim 1, wherein the filling and stoppering is automated.
11. The process according to claim 10, wherein the automated process is high-throughput.
12. The process according to claim 1, wherein the containers are selected from at least one of the group of vials, hypodermic syringes, bottles, cartridges, and capsules.
13. The process according to claim 1 , wherein the fluid comprises a product selected from at least one of a protein, polymer, a polysaccharide, a vaccine, an anti-serum, a mucoprotein, a nucleic acid, and a lipoprotein.
14. The process according to claim 13, wherein the product is recombinant^ produced.
PCT/US2006/041460 2006-01-26 2006-10-24 Process for aseptic vacuum filling and stoppering of low viscosity liquids in containers Ceased WO2007089295A2 (en)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US76223206P 2006-01-26 2006-01-26
US60/762,232 2006-01-26
US79857306P 2006-05-08 2006-05-08
US60/798,573 2006-05-08
US11/584,914 US20070169434A1 (en) 2006-01-26 2006-10-23 Process for aseptic vacuum filling and stoppering of low viscosity liquids in syringes
US11/584,914 2006-10-23

Publications (3)

Publication Number Publication Date
WO2007089295A2 WO2007089295A2 (en) 2007-08-09
WO2007089295A3 WO2007089295A3 (en) 2007-11-22
WO2007089295B1 true WO2007089295B1 (en) 2008-02-28

Family

ID=38284192

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2006/041460 Ceased WO2007089295A2 (en) 2006-01-26 2006-10-24 Process for aseptic vacuum filling and stoppering of low viscosity liquids in containers

Country Status (2)

Country Link
US (1) US7328549B2 (en)
WO (1) WO2007089295A2 (en)

Families Citing this family (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2632608C (en) * 2006-01-17 2013-08-06 Baxter International Inc. Device, system and method for mixing
US20090038701A1 (en) 2006-01-17 2009-02-12 Baxter International Inc. Device, system and method for mixing
WO2007089295A2 (en) 2006-01-26 2007-08-09 Hyaluron, Inc. Process for aseptic vacuum filling and stoppering of low viscosity liquids in containers
US20070175538A1 (en) * 2006-01-30 2007-08-02 Jurgen Rothbauer System and method for filling containers with liquid under varying pressure conditions
EP2051043A1 (en) * 2007-10-17 2009-04-22 SOLA-Messwerkzeuge GmbH Airlessly sealed vial
US8393357B2 (en) 2009-07-08 2013-03-12 Medtronic Minimed, Inc. Reservoir filling systems and methods
US8167846B2 (en) 2009-07-08 2012-05-01 Medtronic Minimed, Inc. Reservoir filling systems and methods
US8641661B2 (en) 2010-01-05 2014-02-04 Baxter International Inc. Mixing system, kit and mixer adapter
CA2726566A1 (en) * 2010-01-11 2011-07-11 Baxter International Inc. Pipette system, pipette tip assembly and kit
MX2014007115A (en) * 2011-12-15 2014-09-08 Sanofi Aventis Deutschland Reservoir or medicated module for a drug delivery system and method of and assembly for filling the same.
US9604184B2 (en) 2013-03-06 2017-03-28 Orthovita, Inc. Mixing system and valve assembly
JP6491195B2 (en) 2013-05-03 2019-03-27 ベクトン・ディキンソン・アンド・カンパニーＢｅｃｔｏｎ， Ｄｉｃｋｉｎｓｏｎ Ａｎｄ Ｃｏｍｐａｎｙ Fluid path subassembly
US10266293B1 (en) 2014-09-15 2019-04-23 Automated Systems of Tacoma LLC Method and system for vacuum stoppering of fluid containers
US11229702B1 (en) 2015-10-28 2022-01-25 Coherus Biosciences, Inc. High concentration formulations of adalimumab
WO2017112755A1 (en) 2015-12-22 2017-06-29 Lifecell Corporation Syringe filling device for fat transfer
WO2017184880A1 (en) * 2016-04-20 2017-10-26 Coherus Biosciences, Inc. A method of filling a container with no headspace
FR3083721B1 (en) 2018-07-12 2020-12-18 Aptar France Sas FLUID PRODUCT DISTRIBUTION DEVICE AND ITS FILLING AND STOPPING PROCESS.

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2503944A (en) * 1946-02-18 1950-04-11 Frascari Joseph Sealing capsule
US3020685A (en) * 1957-11-15 1962-02-13 Frank L Kurek Process and appartus for filling pressure tight cans
US3245194A (en) * 1962-07-31 1966-04-12 B D Lab Inc Method and apparatus for filling hypodermic syringes, ampules, etc.
US3650084A (en) * 1968-01-15 1972-03-21 Scherer Corp R P Method for filling and sealing plastic ampoules
US3733771A (en) * 1971-03-11 1973-05-22 W Megowen Closure means and method
US4623516A (en) * 1981-01-05 1986-11-18 Automatic Liquid Packaging, Inc. Sterilizing method for an encapsulating machine
SE459730B (en) * 1987-12-04 1989-07-31 Kabivitrum Ab APPLIANCES FOR FILLING AND CLOSING BOTTLES CONTAINING A NUMBER OF TREATMENT STATIONS PROVIDED IN A CYCLIC CYCLE
DE19544708A1 (en) * 1995-11-30 1997-06-12 Helmut Geis Bottle containing aseptic cold drink
US5884457A (en) * 1997-02-05 1999-03-23 Smithkline Beecham Corporation Method and apparatus for automatically producing a plurality of sterile liquid filled delivery devices
DE19909995A1 (en) * 1999-03-06 2000-09-07 Inova Pac Systeme Gmbh Syringe filling and evacuating process comprises filling syringe, evacuating it so quickly that the liquid does not boil under reduced pressure and immediately sealing it
DE19918721A1 (en) * 1999-04-24 2000-11-02 Inova Pac Systeme Gmbh Method and device for filling needle-free injectors
US6440842B1 (en) * 2001-02-02 2002-08-27 Macronix International Co. Ltd. Method of forming a dual damascene structure by patterning a sacrificial layer to define the plug portions of the structure
US6688081B2 (en) * 2001-12-18 2004-02-10 Schmalbach-Lubeca Ag Method for reducing headspace gas
WO2007089295A2 (en) 2006-01-26 2007-08-09 Hyaluron, Inc. Process for aseptic vacuum filling and stoppering of low viscosity liquids in containers

Also Published As

Publication number Publication date
US20070169435A1 (en) 2007-07-26
WO2007089295A3 (en) 2007-11-22
US7328549B2 (en) 2008-02-12
WO2007089295A2 (en) 2007-08-09

Similar Documents

Publication Publication Date Title
WO2007089295B1 (en) Process for aseptic vacuum filling and stoppering of low viscosity liquids in containers
EP3208202B1 (en) System for producing vials containing a substance comprising an oxygen-sensitive formulation
JP2017536186A (en) Preparation of double chamber container
EP3049044B1 (en) Cryopreservation container
SG184868A1 (en) Automated filling of flexible cryogenic storage bags with therapeutic cells
Bhatnagar et al. Freeze drying of biologics
TW200706457A (en) Method and apparatus for manufacturing a bottled drink
AU2020210811B2 (en) Reconstitution system to administer a drug via a high vacuum vial with integrated vent conduit
RU2584594C1 (en) Inactivated split influenza vaccine and preparation method thereof
AU2019309168B2 (en) Method of filling at least one degassed drug product into containers and drug product filling device
CN105148812A (en) Treatment device and treatment method for laboratory liquid preparation
US20070169434A1 (en) Process for aseptic vacuum filling and stoppering of low viscosity liquids in syringes
CN2770648Y (en) Plastic injection ampoule
JP7069458B2 (en) Methods and systems for recovering fluids
CN101926763A (en) Method for preparing lipoalprostadil sterile preparation
CN203555974U (en) Device for terminal sterilization of pre-filled preparation
CA2154083A1 (en) Improvements in or relating to carbonation
CN101171331A (en) Multi-step process for the manufacture of therapeutic protein
CN104434517A (en) Double-layer aseptic packaging, packaging method and sterility testing method for large-capacity injection
EP3842115B1 (en) Method and system for recovering fluid
JP7069457B2 (en) Methods and systems for recovering fluids
CN106693003A (en) Glucose-containing lipid emulsion sterilizing method
CN119354446A (en) A method for detecting the leak tightness of low-concentration plastic ampoule-filled liquid medicine
CN100446831C (en) Method for removing organic solvent from heavy-bodied liquid
Henderson Primary container and closure selection for biopharmaceuticals

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application
NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 06817340

Country of ref document: EP

Kind code of ref document: A2